Mian C, Lodde M, Haitel A, Vigl E E, Marberger M, Pycha A
Department of Clinical Pathology, General Hospital of Bolzano, Italy.
Urology. 2000 Feb;55(2):223-6. doi: 10.1016/s0090-4295(99)00383-0.
To compare the diagnostic value of two enzyme-linked immunosorbent assay (ELISA) tests, the nuclear matrix protein 22 (NMP22) test and a newly developed urinary bladder cancer (UBC) test, in patients having symptoms suggestive of urothelial cell carcinoma (UCC) and patients under follow-up after transurethral resection (TUR).
Two hundred forty patients with a mean age of 65.8 years (range 22 to 92) were included in this retrospective study. The tests were performed on previously frozen urine samples. Eighty-one patients had symptoms suggestive of bladder cancer and 159 patients were being followed up after complete TUR of UCC. Voided urine was evaluated by the NMP22 test and the monoclonal UBC-ELISA test, which traces cytokeratins 8 and 18. All patients underwent subsequent cystoscopy and biopsy evaluation of any suspicious lesion. The cutoff levels for bladder cancer positivity were 10 U/mL for the NMP22 test and 12 microg/L for the UBC test.
In the 54 patients with histologically proved UCC, the NMP22 test had a sensitivity of 55.5% and the UBC test a sensitivity of 64.8%. According to the histologic stages, the sensitivity of NMP22 was 51.7% in pTa tumors, 46.1% in pT1, and 70% in pT2 or higher tumors; the sensitivity of UBC was 62.1% in pTa, 53.8% in pT1, and 80% in pT2 or higher tumors. For histologic grades 1 to 3, the sensitivity was 50%, 50%, and 68.7% for NMP22 and 66.6%, 60%, and 68.7% for UBC, respectively. The specificity was 79% and 92% for NMP22 and UBC, respectively.
The monoclonal UBC-ELISA test is superior to the NMP22 test in both sensitivity and specificity. Nevertheless, neither test can replace cystoscopy.
比较两种酶联免疫吸附测定（ELISA）试验，即核基质蛋白22（NMP22）试验和新开发的膀胱癌（UBC）试验，对有尿路上皮细胞癌（UCC）症状患者及经尿道切除术（TUR）后随访患者的诊断价值。
本回顾性研究纳入了240例平均年龄65.8岁（范围22至92岁）的患者。试验在先前冷冻的尿液样本上进行。81例患者有膀胱癌症状，159例患者在UCC完全TUR后接受随访。通过NMP22试验和追踪细胞角蛋白8和18的单克隆UBC - ELISA试验评估晨尿。所有患者随后均接受膀胱镜检查及对任何可疑病变的活检评估。NMP22试验膀胱癌阳性的临界值为10 U/mL，UBC试验为12 μg/L。
在54例经组织学证实为UCC的患者中，NMP22试验的敏感性为55.5%，UBC试验的敏感性为64.8%。根据组织学分期，NMP22在pTa肿瘤中的敏感性为51.7%，在pT1中为46.1%，在pT2或更高分期肿瘤中为70%；UBC在pTa中的敏感性为62.1%，在pT1中为53.8%，在pT2或更高分期肿瘤中为80%。对于组织学1至3级，NMP22的敏感性分别为50%、50%和68.7%，UBC分别为66.6%、60%和68.7%。NMP22和UBC的特异性分别为79%和92%。
单克隆UBC - ELISA试验在敏感性和特异性方面均优于NMP22试验。然而，两种试验都不能替代膀胱镜检查。
